Linvoseltamab BLA for Treatment of Relapsed/Refractory Multiple Myeloma Accepted for FDA Priority Review
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Insights
The FDA's acceptance of the BLA for linvoseltamab under Priority Review signifies a significant step for Regeneron Pharmaceuticals in bringing a novel therapeutic option to patients with R/R multiple myeloma. This condition, being the second most prevalent blood cancer, represents a substantial patient population with a high unmet medical need, particularly after the failure of three prior lines of therapy. The bispecific antibody mechanism of linvoseltamab, aimed at connecting MM cells with T cells for enhanced immune response, is a cutting-edge approach in oncology therapeutics.
Given the incurable nature of MM and the inevitability of disease progression, the development of linvoseltamab could potentially extend remission periods or improve quality of life, which would be a noteworthy advancement in treatment. The ongoing Phase 3 confirmatory trial, alongside additional planned studies, indicates a robust clinical development strategy, potentially expanding the drug's indications and bolstering its therapeutic value. The implications for Regeneron's pipeline and market positioning are considerable, particularly if linvoseltamab demonstrates a favorable safety and efficacy profile upon regulatory review.
Multiple myeloma is a complex disease that often requires multiple lines of therapy due to its refractory and relapsing nature. Linvoseltamab's mode of action, engaging both the B-cell maturation antigen and T cells, represents an innovative approach that could potentially offer a more targeted and effective treatment for patients who have exhausted other options. The clinical outcomes of the LINKER-MM1 trial will be critical in determining the real-world efficacy of linvoseltamab.
From a medical perspective, the potential approval of linvoseltamab introduces an alternative for R/R MM patients, which could translate into prolonged survival rates and improved patient outcomes. The bispecific antibody's ability to directly engage the immune system to combat MM cells is a promising strategy that aligns with the trend towards personalized and precision medicine in oncology.
The market's response to the FDA's Priority Review for linvoseltamab will likely be positive, considering the high demand for new treatments in the R/R MM space. The August 22, 2024 target action date provides a clear timeline for potential market entry, which is crucial for investor expectations. The acceptance of the Marketing Authorization Application by the European Medicines Agency further reinforces the global commercial potential of linvoseltamab.
Regeneron's strategic move to invest in a broad clinical development program for linvoseltamab, including trials for earlier lines of therapy, suggests confidence in its efficacy and safety profile. This could result in a strong competitive edge and diversification of revenue streams for Regeneron, especially if linvoseltamab is approved. Investors will be closely monitoring the Phase 3 trial results for indications of the drug's market viability and long-term financial impact on the company.
TARRYTOWN, N.Y., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. The target action date for the FDA decision is August 22, 2024. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
The BLA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023. Earlier this month, the European Medicines Agency accepted for review the Marketing Authorization Application for linvoseltamab in the same indication.
As the second most common blood cancer, it’s estimated 35,000 people will be diagnosed with MM in the U.S. every year. MM is characterized by the proliferation of cancerous plasma cells (MM cells) that crowd out healthy blood cells in the bone marrow, infiltrate other tissues and cause potentially life-threatening organ injury. MM is not curable despite treatment advances. While current treatments are able to slow the progression of the cancer, most patients will ultimately experience disease progression and require additional therapies.
The linvoseltamab clinical development program includes a Phase 3 confirmatory trial in patients with R/R MM (LINKER-MM3) that is currently enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway, including a Phase 1/2 trial in the first-line setting, a Phase 2 trial in high-risk smoldering MM and a Phase 2 trial in monoclonal gammopathy of undetermined significance. A Phase 1 trial of linvoseltamab in combination with a Regeneron CD38xCD28 costimulatory bispecific in MM is also planned. For more information, visit the Regeneron clinical trials website, or contact via clinicaltrials@regeneron.com or 844-734-6643.
Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.
About the Phase 1/2 Trial
The ongoing, open-label, multicenter Phase 1/2 dose-escalation and dose-expansion LINKER-MM1 trial is investigating linvoseltamab in 282 enrolled patients with R/R MM. Eligibility in the Phase 2 portion required patients to have received at least three prior lines of therapy or have triple-class refractory MM. Linvoseltamab was administered with an initial step-up dosing regimen followed by the full dose. Additionally, in the Phase 2 portion, a response-adapted regimen enabled patients treated with linvoseltamab 200 mg who achieved a very good partial response or a complete response to shift from every two-week to every four-week dosing after a minimum of 24 weeks of therapy.
The Phase 1 dose-escalation portion of the trial, which is now complete, primarily assessed safety, tolerability and dose-limiting toxicities across nine dose levels of linvoseltamab exploring different administration regimens. The Phase 2 dose expansion portion is assessing the safety and anti-tumor activity of linvoseltamab, with a primary endpoint of objective response rate. Key secondary endpoints include duration of response, progression free survival, rate of minimal residual disease negative status and overall survival.
About Regeneron in Hematology
At Regeneron, we’re applying more than three decades of biology expertise with our proprietary VelociSuite® technologies to develop medicines for patients with diverse blood cancers and rare blood disorders.
Our blood cancer research is focused on bispecific antibodies that are being investigated both as monotherapies and in various combinations and emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop customized and potentially synergistic cancer treatments.
Our research and collaborations to develop potential treatments for rare blood disorders include explorations in antibody medicine, gene editing and gene-knockout technologies, and investigational RNA-approaches focused on depleting abnormal proteins or blocking disease-causing cellular signaling.
About Regeneron
Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for over 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center®, which is conducting one of the largest genetics sequencing efforts in the world.
For more information about Regeneron, please visit www.Regeneron.com or follow Regeneron on LinkedIn.
Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. 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| Contacts: | |
| Media Relations Tammy Allen Tel: +1 914-306-2698 tammy.allen@regeneron.com | Investor Relations Vesna Tosic Tel: +1 914-847-5443 vesna.tosic@regeneron.com |
FAQ
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